Health Condition 1: H32- Chorioretinal disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Faricimab (RO6867461): faricimab 6 mg IVT injection administered at up to 104 weeks
Control Intervention1: Nil: Nil
Sponsors
F HoffmannLa Roche Ltd
Roche Products India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Participants who are able to comply with the study protocol, in the investigatorâ??s judgment. For female participants of childbearing potential: agreement to remain abstinent or use contraception. Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis. Confirmed diagnosis, by the investigator, of symptomatic macular PCV. BCVA scores of 78ï?24 ETDRS letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the ETDRS protocol and assessed at the initial testing distance of 4 meters (see the BCVA manual for additional details) on study Day 1
Exclusion criteria
Exclusion criteria: Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1. Any major illness or major surgical procedure within 1 month before screening. Active cancer within the 12 months prior to study Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer. Systemic treatment for suspected or active systemic infection on study Day 1. Uncontrolled blood pressure, while the participant is at rest on study Day 1. History of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of faricimab. History of idiopathic or autoimmune-associated uveitis in either eye. Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1. Any history or presence of macular pathology unrelated to PCV affecting vision or contributing to the presence of macular hemorrhage, IRF, or SRF. Retinal pigment epithelial tear involving the macula on study Day 1. Current vitreous hemorrhage on study Day 1. Uncontrolled glaucoma. Prior periocular pharmacological or IVT treatment (including anti-VEGF medication) for other retinal diseases. Participants who have a non-functioning fellow (non study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non study eye (i.e., monocular), at both the screening and study Day 1 visits will be excluded from study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change from baseline in BCVA (as measured on the ETDRS chart at a starting distance of 4 meters) based on an average at Weeks 40, 44, and 48.Timepoint: Population: adult participants with PCV as defined by the inclusion or exclusion criteria mITT population). Variable: change from baseline in BCVA score averaged over Weeks 40, 44, and 48 as measured using the ETDRS VA chart at a starting distance of 4 meters. Population-level summary: Adjusted mean and associated 95% CI in the faricimab arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of IVT injections of faricimab on additional BCVA outcomesTimepoint: Change from baseline in BCVA based on an average at Weeks 100, 104, and 108 Change from baseline in BCVA over time Proportion of participants avoiding loss or gaining more than equal to 15, more than equal to 10, or more than equal to 5 letters in BCVA from baseline over time;To evaluate the efficacy of IVT injections of faricimab on anatomic outcome measures using ICGATimepoint: Proportion of participants with complete polypoidal lesion regressions at Weeks 16, 48, and 108;To evaluate the efficacy of IVT injections of faricimab on anatomic outcomes measures using OCTTimepoint: Change from baseline in CST based on an average at Weeks 40, 44, and 48 Change from baseline in CST based on an average at Weeks 100, 104, and 108 Change from baseline in CST over time;To evaluate the durability of IVT injections of faricimabTimepoint: Proportion of participants on a Q8W, Q12W, and Q16W treatment interval at Weeks 24, 44, and 108, and Q20W at Week 108. Number of faricimab injections received from Week 48 through Week 108;To evaluate the ocular and non-ocular safety and tolerability of IVT injections of faricimabTimepoint: Incidence and severity of ocular adverse events Incidence and severity of non-ocular adverse events | — |
Countries
China, Hong Kong, India, Japan, Malaysia, Republic of Korea, Singapore, Taiwan, Thailand
Contacts
Public ContactSharad Junnare
Roche Products (India) Pvt. Ltd.
Outcome results
None listed